QuantiFERON®-TB Gold Plus (182879)

QuantiFERON-TB Gold Plus is an in vitro diagnostic test using a peptide cocktail of CD4+ and CD8+ T cell antigens to stimulate cells in heparinized whole blood. Detection of interferon-gamma by enzyme-linked immunosorbent assay (ELISA) is used to identify in vitro responses to these peptide antigens that are associated with Mycobacterium tuberculosis infection. QuantiFERON-TB Gold Plus is an indirect test for M. tuberculosis infection (including disease) and is intended for use in conjunction with risk assessment, radiography, and other medical and diagnostic evaluations.

A negative QFT-Plus result does not preclude the possibility of M. tuberculosis infection or tuberculosis disease: false negative results can be due to stage of infection, co-morbid conditions that affect immune function, incorrect handling of the blood collection tubes following venipuncture, incorrect performance of the assay, or other individual immunological variables. Heterophile antibodies or non-specific interferon-gamma production from other inflammatory conditions may mask specific responses to CD4+ and CD8+ T cell antigens. A positive QFT-Plus result should not be the sole or definitive basis for determining infection with M. tuberculosis. Incorrect performance of the assay may cause false-positive results. A positive QFT-Plus result should be followed by further medical evaluation for active tuberculosis disease.